FDA 101: Dietary Supplements

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The law defines dietary supplements in part as products taken by mouth that contain a
"dietary ingredient." Dietary ingredients include vitamins, minerals, amino acids, and
herbs or botanicals, as well as other substances that can be used to supplement the diet.

Dietary supplements come in many forms, including tablets, capsules, powders, energy
bars, and liquids. These products are available in stores throughout the United States, as
well as on the Internet. They are labeled as dietary supplements and include among others

 vitamin and mineral products

 "botanical" or herbal products—These come in many forms and may include plant
materials, algae, macroscopic fungi, or a combination of these materials.
 amino acid products—Amino acids are known as the building blocks of proteins
and play a role in metabolism.
 enzyme supplements—Enzymes are complex proteins that speed up biochemical
reactions.

People use dietary supplements for a wide assortment of reasons. Some seek to
compensate for diets, medical conditions, or eating habits that limit the intake of essential
vitamins and nutrients. Other people look to them to boost energy or to get a good night's
sleep. Postmenopausal women consider using them to counter a sudden drop in estrogen
levels.

Talk with a Health Care Professional

The Food and Drug Administration (FDA) suggests that you consult with a health care
professional before using any dietary supplement. Many supplements contain ingredients
that have strong biological effects, and such products may not be safe in all people.

If you have certain health conditions and take these products, you may be putting
yourself at risk. Your health care professional can discuss with you whether it is safe for
you to take a particular product and whether the product is appropriate for your needs.
Here is some general advice:

 Dietary supplements are not intended to treat, diagnose, cure, or alleviate the
effects of diseases. They cannot completely prevent diseases, as some vaccines
can. However, some supplements are useful in reducing the risk of certain
diseases and are authorized to make label claims about these uses. For example,
folic acid supplements may make a claim about reducing the risk of birth defects
of the brain and spinal cord.
 Using supplements improperly can be harmful. Taking a combination of
supplements, using these products together with medicine, or substituting them in
place of prescribed medicines could lead to harmful, even life-threatening, results.
 Some supplements can have unwanted effects before, during, or after
surgery. For example, bleeding is a potential side effect risk of garlic, ginkgo
biloba, ginseng, and Vitamin E. In addition, kava and valerian act as sedatives and
can increase the effects of anesthetics and other medications used during surgery.
Before surgery, you should inform your health care professional about all the
supplements you use.

How Are Supplements Regulated?

You should know the following if you are considering using a dietary supplement.

 Federal law requires that every dietary supplement be labeled as such, either with
the term "dietary supplement" or with a term that substitutes a description of the
product's dietary ingredient(s) for the word "dietary" (e.g., "herbal supplement" or
"calcium supplement").
 Federal law does not require dietary supplements to be proven safe to FDA's
satisfaction before they are marketed.
 For most claims made in the labeling of dietary supplements, the law does not
require the manufacturer or seller to prove to FDA's satisfaction that the claim is
accurate or truthful before it appears on the product.
 In general, FDA's role with a dietary supplement product begins after the product
enters the marketplace. That is usually the agency's first opportunity to take action
against a product that presents a significant or unreasonable risk of illness or
injury, or that is otherwise adulterated or misbranded.
 Dietary supplement advertising, including ads broadcast on radio and television,
falls under the jurisdiction of the Federal Trade Commission.
 Once a dietary supplement is on the market, FDA has certain safety monitoring
responsibilities. These include monitoring mandatory reporting of serious adverse
events by dietary supplement firms and voluntary adverse event reporting by
consumers and health care professionals. As its resources permit, FDA also
reviews product labels and other product information, such as package inserts,
accompanying literature, and Internet promotion.
 Dietary supplement firms must report to FDA any serious adverse events that are
reported to them by consumers or health care professionals.
  Dietary supplement manufacturers do not have to get the agency's approval before
producing or selling these products.
 It is not legal to market a dietary supplement product as a treatment or cure for a
specific disease, or to alleviate the symptoms of a disease.
 There are limitations to FDA oversight of claims in dietary supplement labeling.
For example, FDA reviews substantiation for claims as resources permit.

Are Supplements Safe?

Many dietary supplements have clean safety histories. For example, millions of
Americans responsibly consume multi-vitamins and experience no ill effects.

Some dietary supplements have been shown to be beneficial for certain health conditions.
For example, the use of folic acid supplements by women of childbearing age who may
become pregnant reduces the risk of some birth defects.

Another example is the crystalline form of vitamin B12, which is beneficial in people
over age 50 who often have a reduced ability to absorb naturally occurring vitamin B12.
But further study is needed for some other dietary supplements.

Some supplements have had to be recalled because of proven or potential harmful effects.
Reasons for these recalls include

 microbiological, pesticide, and heavy metal contamination

 absence of a dietary ingredient claimed to be in the product
 the presence of more or less than the amount of the dietary ingredient claimed on
the label

In addition, unscrupulous manufacturers have tried to sell bogus products that should not
be on the market at all.

Before taking a dietary supplement, make sure that the supplement is safe for you and
appropriate for the intended purpose.

Be a Safe and Informed Consumer

 Let your health care professional advise you on sorting reliable information from
questionable information.
 Contact the manufacturer for information about the product you intend to use.
 Be aware that some supplement ingredients, including nutrients and plant
components, can be toxic. Also, some ingredients and products can be harmful
when consumed in high amounts, when taken for a long time, or when used in
combination with certain other drugs, substances, or foods.
 Do not self-diagnose any health condition. Work with health care professionals to
determine how best to achieve optimal health.
  Do not substitute a dietary supplement for a prescription medicine or therapy, or
for the variety of foods important to a healthful diet.
 Do not assume that the term "natural" in relation to a product ensures that the
product is wholesome or safe.
 Be wary of hype and headlines. Sound health advice is generally based upon
research over time, not a single study.
 Learn to spot false claims. If something sounds too good to be true, it probably is.

Report Problems

Adverse effects with dietary supplements should be reported to FDA as soon as possible.
If you experience such an adverse effect, contact or see your health care professional
immediately. Both of you are then encouraged to report this problem to FDA. For
information on how to do this, go to https://www.fda.gov/food/dietary-supplements/how-
report-problem-dietary-supplements.

Adverse effects can also be reported to the product's manufacturer or distributor through
the address or phone number listed on the product's label. Dietary supplement firms are
required to forward reports they receive about serious adverse effects to FDA within 15
days.

For a general, nonserious complaint or concern about dietary supplements, contact your
local FDA Consumer Complaint Coordinator.